NCT02178761

Imaging and Interventional Study for Erectile Dysfunction and Lower Urinary Tract Symptoms

Comprehensive Imaging and Interventional Therapy Studies for Arteriogenic Erectile Dysfunction and Lower Urinary Tract Symptoms: A Multi-modality, Multi-Specialty Collaborative Study (PERFECT Program)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Erectile dysfunction is highly prevalent as men grow older. Among the various causes of erectile dysfunction, it has been shown that pelvic arterial insufficiency plays a very important role. The investigators have recently developed the first imaging analytical algorithm by using the abdominal/pelvis multidetector computed tomographic (MDCT) angiography to delineate the whole arterial system supplying the penis. To establish a comprehensive, cutting-edge diagnostic and interventional therapeutic program for erectile dysfunction, the investigators therefore design this series of studies by including experts from Urology, Radiology, and Cardiology. This research project (PERFECT program) includes the following 4 sub-studies: 1) differential frequency of obstructive pelvic arterial lesions in coronary artery disease patients with and without erectile dysfunction/lower urinary tract symptoms (LUTS), 2) differential frequency of obstructive pelvic arterial lesions in patients with vascular risk factors and with or without erectile dysfunction/LUTS, 3) safety, feasibility, and efficacy of comprehensive pelvic angioplasty (with various interventional strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive arterial disease: proof-of-concept study; and 4) efficacy and safety of comprehensive pelvic angioplasty (with various interventional strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive arterial disease: a randomized controlled trial.

Conditions

• Erectile Dysfunction
• Lower Urinary Tract Symptoms
• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	drug-eluting balloon	angioplasty completed with drug-eluting balloons
DEVICE	biodegradable vascular scaffold stent	Stenting with biodegradable vascular scaffold stents
DEVICE	Apex™ PTCA Dilatation Catheter	plain old balloon angioplasty alone
DEVICE	Stent System	stenting with either bare-metal stents or drug-eluting stents

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-07-01
• Last updated: 2014-07-01

Locations

1 site across 1 country: Taiwan